NCT01736696

Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis

Phase 1, Investigator-Blind, Subject-Blind, Sponsor-Open, Placebo-Controlled, Two-Week, Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of CP-690,550

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study was conducted in subjects with psoriasis to evaluate drug activity in this patient population by analysis of changes in psoriatic lesion biopsy characteristics. This subject population was selected to evaluate potentially relevant biological activity of CP-690,550 as well as assessing safety and pharmacokinetics.

Conditions

• Psoriasis
• Immunomodulation

Interventions

Type	Name	Description
DRUG	tofacitinib	5 mg BID For 13 days and once on Day 14
DRUG	tofacitinib	10 mg BID for 13 days and once on Day 14\*
DRUG	tofacitinib	20 mg BID for 13 days and once on Day 14
DRUG	tofacitinib	30 mg BID for 13 days and once on Day 14
DRUG	tofacitinib	60 mg tablet once a day (QD) for 14 days
DRUG	tofacitinib	50 mg tablets two times a day (BID) for 13 days and once on day 14

Timeline

• Start date: 2002-11-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2012-11-29
• Last updated: 2013-02-20
• Results posted: 2013-02-20

Locations

1 site across 1 country: United States